MAUDE Adverse Event Report: STRYKER GMBH IMN INSTRUMENTS - DRILL-TIP RECON K-WIRE D3.2X400MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23513240S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "the tip of the drill-tip recon k-wire broke off.The broken tip was removed from the patient's body immediately and the surgery was completed successfully by using another guide pin.It was determined that this was caused by moving the k-wire before pulling it out during the surgeon's operation.".
Event or Problem Description
As reported: "the tip of the drill-tip recon k-wire broke off.The broken tip was removed from the patient's body immediately and the surgery was completed successfully by using another guide pin.It was determined that this was caused by moving the k-wire before pulling it out during the surgeon's operation.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Based on the information received, it could be confirmed that the implant breakage is user related, "it was determined that this was caused by moving the k-wire before pulling it out during the surgeon's operation".A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: IMN INSTRUMENTS - DRILL-TIP RECON K-WIRE D3.2X400MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23137846
• Report Number: 0008031020-2025-01634
• Device Sequence Number: 13219480
• Product Code: LXH
• UDI-Device Identifier: 07613327361698
• UDI-Public: (01)07613327361698(11)250409(17)350331(10)K11EFFC
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 23513240S
• Device Lot Number: K11EFFC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male